INCORPORATION BY REFERENCE
This report onForm 6-K shall be deemed to be incorporated by reference into the registration statements onForm S-8 (Registration Numbers333-203040,333-210810,333-211512,333-213412,333-214843 and333-216883) andForm F-3 (RegistrationNumbers 333-209336,333-211511,333-216882,333-223134 and333-225284) of Ascendis Pharma A/S (together with its wholly owned subsidiaries, “Ascendis”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
VISEN Pharmaceuticals Formation
On November 8, 2018, Ascendis announced the formation of VISEN Pharmaceuticals (“Visen”), a joint venture established to develop, manufacture and commercialize Ascendis’s endocrinology rare disease therapies in the People’s Republic of China, including Hong Kong, Macau, and Taiwan (“Greater China”). In connection with the formation of Visen and pursuant to Exclusive License Agreements entered into on November 7, 2018 (the “Rights Agreements”), Ascendis, through certain subsidiaries, granted Visen exclusive rights to develop and commercialize therapeutic products based on our proprietary TransCon technology which has been applied to develop novel products that release human growth hormone, parathyroid hormone orC-type natriuretic peptide in Greater China for use in all human indications, subject to certain exceptions. As consideration for the rights granted to Visen under the Rights Agreements, Ascendis, through certain subsidiaries, received 50% ownership in the outstanding shares of Visen and concurrently with the rights Ascendis granted to Visen, entities affiliated with Vivo Capital and Sofinnova Ventures purchased shares in Visen for an aggregate purchase price of $40,000,000.
Rights Agreements
Under the Rights Agreements, Visen must use diligent efforts to develop and commercialize licensed products in Greater China. Additionally, Ascendis and Visen will conduct certain research and development activities allocated to the respective party under a research and technical development plan, and Visen will reimburse Ascendis for costs of conducting such activities, including costs of Ascendis’s personnel committed to performing such activities in Greater China.
Ascendis will provide product supply to Visen for use in conducting clinical trials in Greater China pursuant to separate clinical supply agreements entered into concurrently with the Rights Agreements in accordance with the terms and conditions set forth therein. Additionally, Ascendis and Visen will negotiate in good faith the terms and conditions governing commercial supply of licensed product to Visen on the terms and conditions set forth in the Rights Agreements.
Under the Rights Agreements, Ascendis agreed not to research, develop, or commercialize competing products in Greater China, and Visen agreed not to grant certain rights under its interest in any inventions or intellectual property arising out of the activities conducted under the Rights Agreements to third parties, in each case, under the terms and conditions specified in the Rights Agreements. Ascendis will have the right to exploit inventions and intellectual property arising out of the activities conducted under the Rights Agreements outside of Greater China. Additionally, Ascendis granted Visen a right of first negotiation to develop and commercialize certain of its endocrinology products in Greater China.
The Rights Agreements continue in effect for as long as a valid claim of a licensed patent exists in Greater China. Visen may terminate a Rights Agreement for convenience, for uncured material breach by Ascendis of a Rights Agreement and for our bankruptcy or insolvency-related events. Ascendis may terminate a Rights Agreement for certain specified material breaches thereof by Visen, in the event Visen undergoes a change of control in favor of a competitor, if Visen challenges the validity of any of the licensed patents and for Visen’s bankruptcy or insolvency-related events.
